CEFOTAXIME TORLAN 1000 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION IV/IM

2. What you need to know before starting to use CEFOTAXIMA TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

Do not useCEFOTAXIMA TORLAN 1,000 mg IV/IM

• If you are allergic (hypersensitive) to cefotaxime, other cephalosporins, or any of the other components of CEFOTAXIMA TORLAN 1,000 mg IV/IM
• If you have ever suffered from a severe skin rash or peeling, blisters, or sores in the mouth after taking cefotaxime or other cephalosporins.

Do not use CEFOTAXIMA TORLAN 1,000 mg or inform your doctor if any of the following apply to you

Be careful withCEFOTAXIMA TORLAN 1,000 mg IV/IM

• If you are allergic to penicillins and/or beta-lactam antibiotics. Consult your doctor if you have had any type of allergy to any medication before starting treatment with Cefotaxima TORLAN 1,000 mg IV/IM.
• If you have had any type of immediate allergic reaction to cephalosporins. In case of doubt, the first administration should be done in the presence of a doctor.
• In case of diarrhea, especially if it is severe, persistent, and/or bloody during or after treatment with Cefotaxima TORLAN 1,000 mg IV/IM, consult your doctor as it may be a symptom of disease associated with the germ Clostridium difficile.
• Consult your doctor if you experience any discomfort, especially if you are being treated with Cefotaxima TORLAN 1,000 mg IV/IM for a long time, to rule out another infection by resistant germs (superinfection), or if you experience itching/irritation in the genitals to rule out inflammation in the area due to the germ Candidaspp.
• If you need to be treated for more than 10 days, it is likely that your doctor will consider the convenience of a blood test to rule out the appearance of neutropenia (decrease in the number of white blood cells).
• Some tests, such as the Coombs test and glucosuria, may be positive without being so, due to treatment with this medication.
• If you are going to have any diagnostic tests (blood tests, urine tests...), inform your doctor that you are being treated with this medication, as it may alter the results.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (PEGA), have been reported in association with cefotaxime treatment. Stop taking cefotaxime and seek immediate medical attention if you observe any of the symptoms described in section 4 related to these severe skin reactions.

Use of other medications

Inform your doctor or pharmacist if you are using, or have recently used, other medications, including those purchased without a prescription, homeopathic products, herbal remedies, and other health-related products, as it may be necessary to interrupt treatment or adjust the dose of one of them. Cefotaxima TORLAN should not be administered simultaneously with:

• medications whose active ingredient is probenecid (for the treatment of gout), as the concentration of cefotaxime in the blood increases.
• with nephrotoxic medications (which produce kidney toxicity), especially aminoglycosides, as kidney toxicity is enhanced, and your doctor should monitor kidney function.
• oral contraceptives, as the use of Cefotaxima TORLAN 1,000 mg IV/IM may reduce their effectiveness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

In case of pregnancy, your doctor will decide whether to use this medication.

Breastfeeding women should consult their doctor before using this medication, as cefotaxime passes into breast milk.

Driving and using machines

It is not known whether Cefotaxima TORLAN 1,000 mg IV/IM affects driving or operating machinery. Avoid performing tasks that require special attention until it is known how you tolerate the medication.

Important information about some of the components ofCEFOTAXIMA TORLAN 1,000 mg IV/IM

Patient with low-sodium diets should note that this medication contains 50.5 mg (2.20 mmol) of sodium per dose.

3. How to use CEFOTAXIMA TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

Follow the administration instructions of CEFOTAXIMA TORLAN 1,000 mg IV/IM exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

This medication can be administered intramuscularly by injection or intravenously by slow injection. For intramuscular administration, there are other preparations on the market with lidocaine that reduces pain at the injection site, Cefotaxima TORLAN 1,000 mg powder and solvent for injectable solution intramuscular EFG.

Remember that administration should be done by medical personnel.

Your doctor will indicate the duration of treatment with Cefotaxima TORLAN 1,000 mg IV/IM. Do not suspend treatment before finishing it.

As a general rule, treatments should be extended at least until 3 days after the disappearance of the clinical symptoms of the infection.

Remember to request the administration of your medication.

The normal dose is:

Adults and adolescents (from12 to18 years):the usual dosage is 1 g of cefotaxime every 12 hours.

In severe cases, the daily dose may be increased up to 12 g. If the dose is higher than 2 g, or if Cefotaxima TORLAN 1,000 mg is administered more than 2 times a day, the presentation CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG is recommended. In these cases, if the daily dose is 4 g, it can be divided into 2 doses of 2 g each, administered at 12-hour intervals. If higher doses are necessary, the interval should be reduced.

Pediatric population (under 12 years):According to the severity of the infection, 50-150 mg/kg/day divided into 2, 3, or 4 doses depending on the severity of the infection.

The presentations with 1% lidocaine hydrochloride as solvent should only be used in children over 30 months.

Patients with renal insufficiency:

In patients with decreased renal function, the maintenance dose should be reduced by half.

The initial dose depends on the sensitivity of the pathogen and the severity of the infection.

Hemodialyzed patients:

1 to 2 g daily, depending on the severity of the infection. On the day of hemodialysis, Cefotaxima TORLAN should be administered after the dialysis session.

If you think the action of Cefotaxima TORLAN 1,000 mg IV/IM is too strong or too weak, inform your doctor or pharmacist.

If you use moreCEFOTAXIMA TORLAN 1,000 mg IV/IMthan you should

Consult your doctor immediately or go to the nearest hospital. In case of overdose, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and convulsions) may occur.

In case of accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 91 562 04 20 indicating the medication and the amount used.

If you forget to useCEFOTAXIMA TORLAN 1,000 mg IV/IM

Do not use a double dose to make up for forgotten doses.

If you interrupt treatment withCEFOTAXIMA TORLAN 1,000 mg IV/IM

Do not suspend treatment before finishing it, as the desired effect will not be achieved. It is very important to treat infections for the recommended time; otherwise, they may worsen.

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, CEFOTAXIMA TORLAN 1,000 mg IV/IM can cause adverse effects, although not all people experience them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Stop using cefotaxime and inform your doctor immediately if you observe any of the following symptoms:

• Red patches, or circular or target-shaped patches on the chest, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized skin rash, elevated body temperature, and enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

• Generalized skin rash, red and scaly, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

The following adverse effects have been reported according to the frequencies detailed below:

Frequent: at least 1 in 100 patients

Uncommon: at least 1 in 1,000 patients

Rare: at least 1 in 10,000 patients

Very rare: less than 1 in 10,000 patients

Frequency not known: cannot be estimated from available data

Blood and lymphatic system disorders:

Rare: decrease in the number of white blood cells (neutropenia) and hemolytic anemia (decrease in the number of red blood cells in the blood).

Very rare: decrease in granulocytes (agranulocytosis), particularly if cefotaxime is administered for prolonged periods.

Frequency not known: eosinophilia (increase in a certain group of white blood cells) and thrombocytopenia (reduction in the number of platelets), which are rapidly reversible when treatment is discontinued.

Immune system disorders:

Very rare: allergic reactions on the skin and severe allergic reaction with difficulty breathing and even loss of consciousness (anaphylaxis) that can lead to anaphylactic shock (severe allergic reaction that can be life-threatening).

Nervous system disorders:

Uncommon: at high doses, particularly in patients with renal insufficiency, encephalopathy (deterioration of consciousness, abnormal movements, and convulsions) may occur.

Cardiac disorders:

Frequency not known: arrhythmia (changes in heart rhythm) in case of rapid central intravenous injection.

Gastrointestinal disorders:

Frequent: nausea, vomiting, abdominal pain, or diarrhea.

Diarrhea can sometimes be a symptom of enterocolitis (inflammation of the small intestine and colon), which can be accompanied by blood in the stool. There is a particular form of enterocolitis that can occur with antibiotics.

Hepatobiliary disorders:

Uncommon: increase in liver enzymes and/or bilirubin. Hepatitis (inflammation of the liver) with yellowing of the skin, mucous membranes, or eyes.

Skin and subcutaneous tissue disorders:

Frequent: rash (exanthema), itching (pruritus), and less frequently, hives, irritation, and itching of the skin (urticaria).

Frequency not known: vesicular rashes (skin rashes in the form of blisters), as with other antibiotics of this type.

Renal and urinary disorders:

Uncommon: decreased kidney function (increased creatinine), especially if treated simultaneously with aminoglycosides.

Transient elevation of urea nitrogen has also been observed.

Very rare: interstitial nephritis (allergic-type kidney inflammation).

Reproductive system and breast disorders:

Uncommon: candidiasis (infection by Candida-type fungi), vaginitis (inflammation of the vaginal mucosa).

General disorders and administration site conditions:

Frequent: inflammation of the vein wall and pain at the injection site, which can be avoided by administering Cefotaxima TORLAN more slowly (3 to 5 minutes).

Others:

Fever.

Especially in the case of prolonged treatments, other infections due to organisms not sensitive to Cefotaxima TORLAN (cefotaxime) may appear.

In the case of treatment for borreliosis (infection by Borrelia), a Jarisch-Herxheimer reaction (inflammatory reaction) may appear in the first few days, and after several weeks, other symptoms similar to those of the disease may appear.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

5. Storage of CEFOTAXIMA TORLAN 1,000 mg powder and solvent for injectable solution IV/IM

Keep out of the reach and sight of children.

Store in the original container to protect it from light.

Do not store at a temperature above 25°C.

The reconstituted solution with the solvent is stable for 3 hours at a temperature not exceeding 25°C and for 6 hours if stored in the refrigerator (2-8°C).

Do not use CEFOTAXIMA TORLAN 1,000 mg IV/IM after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown away down the drain or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Additional Information

Composition ofCEFOTAXIMA TORLAN 1,000 mg IV/IM

The active ingredient is cefotaxime (as cefotaxime sodium).

Each vial contains 1,000 mg of cefotaxime (as cefotaxime sodium).

The other components are: water for injectable preparations.

Appearance of the product and packaging content

CEFOTAXIMA TORLAN 1,000 mg IV/IM is presented in the form of a powder, white or almost white, or slightly yellowish, and solvent for injectable solution. It is presented in boxes with 1 vial with 1,000 mg of cefotaxime powder and 1 ampoule of 4 ml of water for injectable preparations as a solvent and clinical packages with 100 vials and 100 ampoules of solvent.

Other presentations

CEFOTAXIMA TORLAN 500 mg powder and solvent for injectable solution EFG: box with 1 vial + 1 ampoule of 2 ml of water for injectable preparations. Clinical package with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG: box with 1 vial + 1 ampoule of 4 ml of lidocaine hydrochloride solution (40mg/4ml). Clinical package with 100 vials + 100 ampoules.

CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG: box with 1 vial + 1 ampoule of 10 ml of water for injectable preparations. Clinical package with 100 vials + 100 ampoules.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

LDP-LABORATORIOS TORLAN, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

Barcelona

This prospectus was approved in: April 2024

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Warning: Use exclusively by a healthcare professional

This information is intended only for doctors or healthcare professionals:

-Stability of the reconstituted cefotaxime solution:

After reconstitution, cefotaxime can be stored for up to 3 hours at a temperature below +25°C and up to 6 hours between +2 and +8°C.

The slightly yellow color of the solution does not indicate alteration of the efficacy of the antibiotic, nor its tolerance. Solutions with a brown or dark yellow color should not be administered.

The stability of the cefotaxime solution at a concentration of 1g/250 ml is satisfactory in the following perfusion liquids:

• Sodium chloride 0.9%
• Glucose 5%
• Ringer's solution
• Sodium lactate

How to prepare this medication

CEFOTAXIMA TORLAN 1,000 mg IV/IM will be administered according to the following instructions:

With the injection of cefotaxime, inflammatory reactions of the venous wall and pain at the injection site have been observed, which can be avoided with slower administration (3 to 5 minutes).

Recently, some cases of life-threatening arrhythmias have been reported in patients who received cefotaxime by rapid intravenous administration through a central venous catheter, so it is recommended to administer it by slow intravenous administration in 3 to 5 minutes.

Intravenous route

For intravenous injection: CEFOTAXIMA TORLAN 1,000 mg IV/IM is administered by slow intravenous injection in 3 to 5 minutes, after dilution in solvent, directly into the vein or through the distal end of the perfusion tube, after clamping it.

If higher doses are required, or if CEFOTAXIMA TORLAN 1,000 mg is administered more than 2 times a day, there are other presentations more suitable for perfusion, CEFOTAXIMA TORLAN 2,000 mg powder and solvent for injectable solution and for perfusion EFG.

For intravenous perfusion: The ampoule of solvent included in the package containing 10 ml of water for injectable preparations should never be used.

For rapid perfusion, 2 g of CEFOTAXIMA TORLAN will be dissolved in 40 ml of water for injectable preparations or a conventional perfusion solution and will be perfused over a period of 20 minutes.

For slow perfusion, 2 g of CEFOTAXIMA TORLAN will be dissolved in 100 ml of isotonic saline or glucose solution and will be perfused over 50 to 60 minutes (other usual perfusion solutions can also be used, except those containing sodium bicarbonate).

Intramuscular route

For intramuscular injection, the vial of CEFOTAXIMA TORLAN 1,000 mg IV/IM will be dissolved in the ampoule that comes with water for injectable preparations and the freshly prepared solution will be injected into the gluteal region by deep intramuscular injection. The pain resulting from the intramuscular injection can be alleviated by dissolving CEFOTAXIMA TORLAN 1,000 mg IV/IM in 4 ml of 1% lidocaine solution. There are other presentations on the market that contain lidocaine CEFOTAXIMA TORLAN 1,000 mg powder and solvent for intramuscular injectable solution EFG.

Lidocaine should never be administered to children under 30 months. It is advised not to inject more than 4 ml into each gluteal region.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/